N.H. Admin. Code § Ph 2005.02

Current through Register No. 50, December 12, 2024

Section Ph 2005.02 - Renewal Application Where Obtained and Filed

(a) Applications for the renewal of a license to operate a 503B outsourcing facility, "Renewal - Bulk Sterile & Non-Sterile Compounders (Including FDA Registered 503B Outsourscing Facilities)", form Ph OF-2, revised June 2017, may be obtained from the board's website at www.oplc.nh.gov/pharmacy, and shall be filed at, the board office. Alternatively, renewal applications may be filed online at https://nhlicenses.nh.gov/eGov/Login.aspx

(b) The applicant shall indicate his or her title, and sign and date the application form under the following affirmation:

"I affirm that I am the person authorized to sign this application for licensure and affirm that this application (including any accompanying documents) has been examined by me and to the best of my knowledge and belief is a true, correct and complete application, and if the registration herein applied for is granted, I hereby agree to and do submit to the jurisdiction of the New Hampshire Board of Pharmacy and to the laws and rules of this State. I understand that as an outsource facility I am required to comply with current Good Manufacturing Practice (cGMP) standards. I have read and understand the testing requirements required for shipping compounded products into New Hampshire."

(c) The applicant shall submit the following documents with the application form:

(1) If shipping controlled drugs, a copy of the facility's current DEA registration;

(2) If licensed by the applicant's home state, a copy of the current license; and

(3) I f applicable, a copy of the most recent inspection report from the applicant's home state; and

(4) If applicable, a copy of:

a. The most recent FDA inspection report;

b. The FDA issued Form 483; and

c. The applicant's response to the Form 483.

N.H. Admin. Code § Ph 2005.02

Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.

Amended by Volume XL Number 46, Filed November 12, 2020, Proposed by #13117, Effective 10/15/2020, Expires 10/15/2030